Overview

Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Lithium Carbonate
Quetiapine Fumarate
Valproic Acid
Criteria
Inclusion Criteria:

- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I
Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent
Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic
and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)

- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index
episode.

- Able to understand and comply with the requirements of the study.

Exclusion Criteria:

- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with
medication within the past year.

- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood
stabilizer, as judged by the investigator.

- Previously randomized into this study or D1447C00126